Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis

BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness o...

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Published inRegional anesthesia and pain medicine Vol. 43; no. 1; pp. 84 - 91
Main Authors Davis, Tim, Loudermilk, Eric, DePalma, Michael, Hunter, Corey, Lindley, David, Patel, Nilesh, Choi, Daniel, Soloman, Marc, Gupta, Anita, Desai, Mehul, Buvanendran, Asokumar, Kapural, Leonardo
Format Journal Article
LanguageEnglish
Published England Copyright by American Society of Regional Anesthesia and Pain Medicine 01.01.2018
BMJ Publishing Group LTD
Lippincott Williams & Wilkins
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Abstract BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).
AbstractList Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection. ClinicalTrials.gov (NCT02343003).
Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.This is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.There were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.This study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.ClinicalTrials.gov (NCT02343003).CLINICAL TRIAL REGISTRATIONClinicalTrials.gov (NCT02343003).
BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain. METHODSThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention. RESULTSThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRSpain reduction 50% or greater74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events. CONCLUSIONSThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).
Background and ObjectivesOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating radiofrequency ablation for OA-related knee pain are lacking. This study compared long-term clinical safety and effectiveness of cooled radiofrequency ablation (CRFA) with intra-articular steroid (IAS) injection in managing OA-related knee pain.MethodsThis is a prospective, multicenter, randomized trial with 151 subjects with chronic (≥6 months) knee pain that was unresponsive to conservative modalities. Knee pain (Numeric Rating Scale [NRS]), Oxford Knee Score, overall treatment effect (Global Perceived Effect), analgesic drug use, and adverse events were compared between CRFA and IAS cohorts at 1, 3, and 6 months after intervention.ResultsThere were no differences in demographics between study groups. At 6 months, the CRFA group had more favorable outcomes in NRS: pain reduction 50% or greater: 74.1% versus 16.2%, P < 0.0001 (25.9% and 83.8% of these study cohorts, respectively, were nonresponders). Mean NRS score reduction was 4.9 ± 2.4 versus 1.3 ± 2.2, P < 0.0001; mean Oxford Knee Score was 35.7 ± 8.8 vs 22.4 ± 8.5, P < 0.0001; mean improved Global Perceived Effect was 91.4% vs 23.9%, P < 0.0001; and mean change in nonopioid medication use was CRFA > IAS (P = 0.02). There were no procedure-related serious adverse events.ConclusionsThis study demonstrates that CRFA is an effective long-term therapeutic option for managing pain and improving physical function and quality of life for patients with painful knee OA when compared with IAS injection.Clinical Trial RegistrationClinicalTrials.gov (NCT02343003).
Author Lindley, David
Soloman, Marc
Kapural, Leonardo
Loudermilk, Eric
Desai, Mehul
Davis, Tim
Gupta, Anita
DePalma, Michael
Hunter, Corey
Patel, Nilesh
Choi, Daniel
Buvanendran, Asokumar
AuthorAffiliation From the Orthopedic Pain Specialists, Santa Monica, CA; †Piedmont Comprehensive Pain Management Group, Greenville, SC; ‡Virginia iSpine Physicians, Richmond, VA; §Ainsworth Institute of Pain, New York, NY; ∥Interventional Pain Management of Texas, Mineral Wells, TX; Advanced Pain Management, Greenfield, WI; ††Valley Pain Consultants, Scottsdale; and ‡‡Valley Anesthesia Consultants, Phoenix, AZ; §§Department of Anesthesiology and Perioperative Medicine, Drexel University, Philadelphia, PA; ∥∥International Spine, Pain & Performance Center, Washington, DC; Department of Anesthesiology, Rush University Medical Center, Chicago, IL; and †††Center for Clinical Research, Winston Salem, NC
AuthorAffiliation_xml – name: From the Orthopedic Pain Specialists, Santa Monica, CA; †Piedmont Comprehensive Pain Management Group, Greenville, SC; ‡Virginia iSpine Physicians, Richmond, VA; §Ainsworth Institute of Pain, New York, NY; ∥Interventional Pain Management of Texas, Mineral Wells, TX; Advanced Pain Management, Greenfield, WI; ††Valley Pain Consultants, Scottsdale; and ‡‡Valley Anesthesia Consultants, Phoenix, AZ; §§Department of Anesthesiology and Perioperative Medicine, Drexel University, Philadelphia, PA; ∥∥International Spine, Pain & Performance Center, Washington, DC; Department of Anesthesiology, Rush University Medical Center, Chicago, IL; and †††Center for Clinical Research, Winston Salem, NC
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BackLink https://www.ncbi.nlm.nih.gov/pubmed/29095245$$D View this record in MEDLINE/PubMed
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ContentType Journal Article
Copyright Copyright © 2018 by American Society of Regional Anesthesia and Pain Medicine.
Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine.2017
Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine. 2017 Lippincott Williams & Wilkins
Copyright_xml – notice: Copyright © 2018 by American Society of Regional Anesthesia and Pain Medicine.
– notice: Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine.2017
– notice: Copyright © 2017 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Society of Regional Anesthesia and Pain Medicine. 2017 Lippincott Williams & Wilkins
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Snippet BACKGROUND AND OBJECTIVESOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous...
Osteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous studies evaluating...
Background and ObjectivesOsteoarthritis (OA) of the knee affects the aging population and has an associated influence on the health care system. Rigorous...
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SubjectTerms Ablation
Adrenal Cortex Hormones - administration & dosage
Adrenal Cortex Hormones - adverse effects
Aged
Analgesics - therapeutic use
Arthralgia - diagnosis
Arthralgia - etiology
Arthralgia - physiopathology
Arthralgia - therapy
Arthritis
Betamethasone - administration & dosage
Betamethasone - adverse effects
Catheter Ablation - adverse effects
Chronic and Interventional Pain: Original
Clinical trials
Combined Modality Therapy
Cross-Over Studies
Denervation - adverse effects
Denervation - methods
Female
Humans
Immunomodulators
Injection
Injections, Intra-Articular
Knee
Knee Joint - drug effects
Knee Joint - innervation
Knee Joint - surgery
Male
Methylprednisolone - administration & dosage
Methylprednisolone - adverse effects
Methylprednisolone - analogs & derivatives
Methylprednisolone Acetate
Middle Aged
Osteoarthritis
Osteoarthritis, Knee - complications
Osteoarthritis, Knee - diagnosis
Osteoarthritis, Knee - physiopathology
Osteoarthritis, Knee - therapy
Pain
Pain management
Pain Measurement
Prospective Studies
Quality of life
Regional anesthesia
Time Factors
Treatment Outcome
Triamcinolone Acetonide - administration & dosage
Triamcinolone Acetonide - adverse effects
United States
Title Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation With Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis
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